MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	MF-410470
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069); Lymphoma (3263)
Date of Event	03/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.The reported events of capsular contracture and seroma are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: "fluid" and capsular contracture, baker grade iv.
Event or Problem Description
Healthcare professional reported a left side "fluid" and capsular contracture, baker grade iv.Device remains implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b.5, b.6, b.7, h.6.Date of alcl diagnosis has not been provided.The event of lymphoma is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.
Event or Problem Description
Healthcare provider additionally reported "pain, hard, immobile, and radiology test came back positive for lymphoma." pathological markers confirming alcl have not been received.
Event or Problem Description
Device has been explanted.
Additional Manufacturer Narrative
Continued h6: f2201, f2203.Previous medwatch submission noted lymphoma-alcl-suspected.Upon review of received follow-up, allergan medical safety has confirmed that there is no malignancy.
Event or Problem Description
Ultrasound showed fluid collection around both breasts which was confirmed via mri.Patient had a diagnosis of late onset seroma (100cc).Cytology at implant exchange was negative for alcl.Bilateral capsulectomy performed and removal of textured implants.Re-augmentation with smooth surfaced implants.

• Brand Name: STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 10102807
• Report Number: 9617229-2020-07996
• Device Sequence Number: 2625228
• Product Code: FTR
• UDI-Device Identifier: 10888628003491
• UDI-Public: 10888628003491
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2019
• Device Model Number: MF-410470
• Device Catalogue Number: MF-410470
• Device Lot Number: 2683533
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2020
• Supplement Date Received by Manufacturer: 07/16/2020; 08/13/2020; 01/29/2021
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 08/14/2020; 09/11/2020; 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR